Navigation Links
Northwestern Survey Finds FDA Predictability a Top Concern Among Medtech Firms; Europe Preferred for Product Approval
Date:5/24/2011

urvey, investigators queried product designers and developers, entrepreneurs, academic physician inventors, and regulatory affairs professionals -- all of whom have been involved with the submission of 510(k) products in the past three years.

The survey is part of a larger study, "A Comprehensive Analysis of the FDA 510(k) Process: Industry Practice and the Implications for Reform." Over the next several months, investigators intend to expand on the survey findings by compiling case studies and performing a more in-depth examination of the U.S. and EU regulatory processes.

The survey builds on the investigators' previous InHealth-funded research with colleagues at Stanford that for the first time documented in detail the medical technology development process. That study, published in the June 2009 issue of the Journal of Medical Devices, found that almost half of all activities and decisions in the development process are affected by regulatory requirements.

The study is funded by the Institute for Health Technology Studies (InHealth), a nonprofit foundation that supports research and analysis into the role of medical technology in advancing healthcare and patient quality of life.

About InHealth (www.inhealth.org) Launched in 2004, the Institute for Health Technology Studies is a nonprofit research and educational organization supporting independent analyses of the social and economic effects of diagnostic and therapeutic medical devices.Contact: Robyn Stein/Caitlin Hool212-220-4444robyn.stein@gabbe.com / caitlin.hool@gabbe.com<
'/>"/>

SOURCE The Institute for Health Technology Studies (InHealth)
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Northwestern Memorial Maintains Top Status in Nursing Hospital Renewed for Nurse Magnet®
2. Lung Cancer Patients the Centerpiece for Northwestern Medicine Quality of Care Study
3. New Implant Device Remotely Monitors Heart Failure Patients at Northwestern Memorials Bluhm Cardiovascular Institute
4. CellCyte Genetics Signs Collaborative Agreement With Northwestern Universitys Feinberg School of Medicine to Perform Disease Model Outcome Study of CellCytes CCG-TH30 Product Candidate
5. Evanston Northwestern Healthcare Researchers Explain Effects of Large-Scale, Universal MRSA Surveillance Program That Supports Expanded Intervention
6. Northwestern Memorial Study Tests Cancer Drug on Scleroderma Patients
7. Northwestern Offers Clinical Research and Regulatory Administration Graduate Certificate Program
8. Northwestern Memorial Transplant Program Initiates New Study
9. Perceptive Informatics® Global Survey Results Indicate Growing Demand for CTMS to Assist in More Efficient Site Monitoring and Management
10. Reportlinker Adds Advanced Lung Cancer in Patient Smoker with Squamous Cell: Clinical Insights from a US Oncologists Survey
11. Transgenomic, Inc. Expands SURVEYOR® Scan Product Line With BRAF and PIK3CA Mutation Detection Kits
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2015)... Aug. 27, 2015 NorthStar Anesthesia , one ... it has been selected by Mercy, based in ... four of their hospitals:  Mercy St. Vincent  Medical Center and ... , Mercy St. Charles  Hospital in Oregon ... Tiffin . "As we looked to ...
(Date:8/27/2015)... TORONTO , Aug. 27, 2015 /PRNewswire/ ... announced the issuance of a white paper on the ... spray product.  The white paper was presented to the ... by Dr. James H. Anderson, Jr. , MD, ... be viewed online on the Generex website. ...
(Date:8/27/2015)...  BioElectronics Corporation (OTC Pink: BIEL), the maker of ... featuring the use of ActiPatch®, its novel musculoskeletal pain ... Congress of the European Pain Federation EFIC®, ... The Company will also be exhibiting at the Congress ... , department clinical and experimental rheumatology from the University ...
Breaking Medicine Technology:Four Mercy Hospitals in Northwest Ohio Select NorthStar Anesthesia 2Generex Announces Issuance of Buccal Insulin White Paper 2Generex Announces Issuance of Buccal Insulin White Paper 3Generex Announces Issuance of Buccal Insulin White Paper 4BioElectronics Selected to Present its Pain Research and Devices at the European Pain Federation Conference 2
... BURLINGTON, Mass., Dec. 7, 2010 ... cardiovascular diagnostic imaging technologies, today announced the publication of ... association of stent thrombosis with lipid core plaque as ... is the first and only FDA-approved system to provide ...
... 2010 Cymetrix, a leader in providing healthcare ... announced an alliance with Siemens Healthcare for financial ... partnership, Cymetrix will assist in the transition of ... systems to Siemens Soarian®. Cymetrix,s system conversion solution ...
Cached Medicine Technology:InfraReDx Announces Publication of a Case Report in Circulation Highlighting Novel Clinical Finding with LipiScan™ Coronary Imaging System 2Cymetrix Forms Alliance With Siemens Healthcare for System Conversion Support 2
(Date:8/28/2015)... Beach, FL. (PRWEB) , ... August 28, 2015 ... ... problems for businesses nationwide. Addictions specialist, Dr. James Strawbridge, gives a new approach ... believes that it should begin with the employer and employees getting together for ...
(Date:8/28/2015)... , ... August 28, 2015 , ... ... patient loyalty at a low cost. Personalized with practice contact information and logos, ... patients. Dental offices can also incorporate Calendars into seasonal mailings, thank you and ...
(Date:8/28/2015)... ... August 28, 2015 , ... Healthpointe clinics ... to go deep sea diving. The act of recreational diving exposes the ... these reasons, it is vital that all recreational and professional divers undergo regular ...
(Date:8/28/2015)... ... 28, 2015 , ... Popular review site Top5MillionaireDatingSites.com recently published ... . According to the listings, MillionaireMatch.com bags the top spot while ... spokesperson of Top5MillionaireDatingSites.com said, “This website has been designed to assist ...
(Date:8/28/2015)... ... August 28, 2015 , ... Inc. magazine today ranked PREVENT Life Safety ... the nation’s fastest-growing private companies. The list was unveiled online at Inc.com and is ... the last three years, PREVENT ranks higher on the list than any other company ...
Breaking Medicine News(10 mins):Health News:SmartPractice® Introduces 2016 Calendars for Dental Practice Giveaways 2Health News:Healthpointe Now Offering Scuba Physicals 2Health News:Top5MillionaireDatingSites.com Publishes Its First List of Reviews of the Best Millionaire Dating Sites 2Health News:PREVENT Life Safety Ranks No. 3660 on the 2015 Inc. 5000 With Three-Year Sales Growth of 85% 2
... the gold standard for detecting colon cancer. But many patients ... invasive test.// Recently, a fecal occult blood stool test has ... stool. However, the test misses a majority of cancers. The ... say the results are encouraging. ,“A simple, non-invasive test ...
... unknown origin are the eighth leading type of cancers. ... Profiling // may now help identify where tumors first ... about 86-percent accurate in determining a tumor’s origin. ... tumor type. Giving the wrong treatment may slow recovery ...
... change in body position may increase an individual’s chances of ... recent study . ,The research is based on a ... or a transient ischemic attack (TIA), also known as a ... common, occur when blood flow to the brain is reduced. ...
... treatment with the oral drug bosentan (Tracleer) has led ... arterial hypertension ( PAH) // . ,PAH is ... is believed to cause the overproduction of endothelin, which ... obstructed. This chronic obstruction leads to PAH, a condition ...
... shows a diet rich in omega-3 and omega-6 fatty acids may ... Researchers say they studied mice to determine the effects of a ... animals were divided into four groups. The first received a diet ... a diet rich in omega-6 fatty acids along with the drug ...
... According to latest research patients who were treated for ... of vitamin B12 in their blood.// An increasing amount ... B and depression, but the specifics have not been ... relationship of vitamin B12 and the treatment of depression. ...
Cached Medicine News:
Inquire...
The model 55D Rocking Shaker provides the same Reliable quality as the 55S, but double the value. The 55D gives you an additional platform with a height of 3.25 in....
Multi-Tier Shaker...
... shake up to 16 of AutoGen's tube units ... This new system is most appropriate for bacterial ... digestion. Now you can further simplify your ... our AutoIncubator 96 and then placing our 6-hole ...
Medicine Products: